MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for MDS86845BM manufactured by Medline Industries Inc..
[183553279]
It was reported that a (b)(6) year old female was ambulating in the hallway after getting out bed. According to the customer, her mother, the end user, grabbed the rollator, which hit the door in the bedroom and the left front wheel came off causing the end user to fall to the floor. The customer stated the ambulance was called and the end user was taken to the hospital, where the end user was diagnosed with a broken bone in her spine. The end user required unspecified rehab for the injury to her spine. The sample was not returned to the manufacturer for evaluation. No additional information is available. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[183553280]
It was reported that the end user fell when her rollator hit the door and she fractured her spine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2020-00022 |
| MDR Report Key | 9836279 |
| Report Source | CONSUMER |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 6434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROLLATOR, EMPOWER, BLUE |
| Product Code | ITJ |
| Date Received | 2020-03-16 |
| Catalog Number | MDS86845BM |
| Lot Number | 86718120007 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-16 |